FDA Medical Device Recalls (openFDA)
Greiner Bio-One GmbH: VACUETTE SAFELINK, REF: 450210
- Recall number
- Z-0802-2025
- Recalling firm
- Greiner Bio-One GmbH
- Product
- VACUETTE SAFELINK, REF: 450210
- Status
- Open, Classified
- Initiated
- 2024-11-19
- Posted
- 2025-01-03
- Terminated
- not on file
- Reason
- The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.
- Root cause
- Process control
- Action
- On 11/19/2024, customers and distributors were mailed and emailed recall notices asking them to do the following: 1) Stop using and isolate affected devices. 2) If the product has been further distributed or transferred to another location, notify those locations of the recall, and advise the name/location in the provided space on the attached Product Disposition Site Confirmation. 3) Complete and return the Product Disposition Site Confirmation form via email to recalls.us@gbo.com If you have additional questions, contact the firm's Technical Service Department at 800-515-8112.
- Quantity
- 188,800 pcs
- Distribution
- US Nationwide distribution in the states of IL, PA.
- Lot, serial or model codes
- UDI-DI: 19120049207487, Lot: A240338Q, Expiration Date: 270215
- 510(k) numbers
- ["K180545"]
- PMA numbers
- not on file
- Product code
- FMI
- Firm FEI
- 3000974732
- Firm city
- Kremsmunster
- Firm state
- not on file
- Firm country
- Austria
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28